Mylan has formed a strategic review committee to evaluate alternatives for its businesses following weak second-quarter performance in its North American segment. Mylan says the profile of the company has changed over the last several years by shifting its core from a US-centric operation to an international presence.

“Our international business, in which we expect continued growth, now represents more than 60% of the company’s global sales,” Mylan said in an August 8, 2018 company statement. “These global growth expectations are in contrast to the negative trends and dynamics playing out in the US marketplace, which we believe are unsustainable for the healthcare system over the long-term but which we believe Mylan is uniquely well positioned to successfully weather and navigate.”

The formation of this strategic review committee follows the release of Mylan’s second-quarter 2018 results, in which the company reported revenues of $2.81 billion, down 5% compared to the prior year period. The company reported North America segment net sales of $1 billion, down 22% compared to the year-ago period. The company reported Europe segment net sales of $990.6 million, up 4% and Rest of World segment net sales of $764.1 million, up 10%.

“Our Europe and Rest of World segments continue to deliver growth in line with our expectations. However, our efforts to serve patients in the US have been shaped by the industry’s transformation there, and our results and guidance for 2018 are directly correlated with the ongoing rebasing of the US healthcare environment,” said Mylan CEO Heather Bresch, in the company’s August 8, 2019 earnings statement.

Mylan says the profile of the company has changed over the last several years by shifting its core from a US-centric operation to an international presence. “…[W]e believe that the US public markets continue to underappreciate and undervalue the durability, differentiation and strengths of Mylan’s global diversified business, especially when compared to our peers around the globe,” Mylan said in its statement. “Therefore, while we will continue to execute on our best-in-class, long-term focused sustainable strategy, the Board has formed a strategic review committee and is actively evaluating a wide range of alternatives to unlock the true value of our one-of-a-kind platform.”

Mylan noted the board has not set a timetable for its evaluation of alternatives and there can be no assurance that any alternative will be implemented.

Additional news: Generic approved for EpiPen products and manufacturing issues

In separate news, the US Food and Drug Administration has approved generic versions of Mylan’s EpiPen and EpiPen Jr (epinephrine injection, USP), auto-injector-based epinephrine products for treating adverse allergic reactions by Teva Pharmaceutical Industries.

Mylan came under US government attention in 2016 regarding the pricing of its EpiPen products. It subsequently revised its pricing for the product, increased access to the product, launched an authorized generic of the product, and finalized a $465-million settlement with the US government with regard to the classification of the product under the Medicaid Drug Rebate Program. In 2017, sales of Mylan’s EpiPen Auto-Injector declined approximately $655.4 million from the prior year as a result of the impact of the launch of the authorized generic, higher governmental rebates as a result of the Medicaid Drug Rebate Program Settlement, and increased competition. In 2016, worldwide sales, which were primarily in North America, were approximately $1 billion.

Mylan also reported earlier this month (August 2018) that its manufacturing partner, Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen (epinephrine injection, USP) 0.3-mg and EpiPen Jr (epinephrine injection, USP) 0.15-mg auto-injectors. “Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies,” said Mylan in an August 8, 2018 release. “We are actively exploring several options with Pfizer that would help stabilize supply. We will continue to provide updates, including timing for resolution, as we receive them from Pfizer.”

Source: Mylan (stategic review statement), Mylan (earnings release), Mylan (EpiPen statement), and Teva Pharmaceutical Industries